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A Study of the Efficacy and Safety of GB-0998 in Patients With Unexplained Recurrent Miscarriage

NCT02184741 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2022-01-28

No results posted yet for this study

Summary

The present survey was conducted to evaluate the efficacy and safety of GB-0998(immunoglobulin) in the treatment of unexplained recurrent miscarriage in comparison to placebo using a multicenter, double-blind, intergroup comparison method.

Conditions

  • Recurrent Miscarriage

Interventions

DRUG

GB-0998

Subjects received GB-0998 at 400 mg/kg body weight once daily for 5 days until 6 weeks and 6 days of gestation after confirmation of the gestational sac by ultrasonography.

DRUG

Placebo

Subjects received the same dose of saline as GB-0998 for 5 days after confirmation of the gestational sac by ultrasonography, up to 6 weeks and 6 days of gestation.

Sponsors & Collaborators

  • Japan Blood Products Organization

    lead INDUSTRY

Principal Investigators

  • Hideto Yamada, Director · Center for Recurrent Pregnancy Loss, Teine Keijinkai Hospital

  • Shigeru Saito, Professor · University of Toyama

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
41 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-03
Primary Completion
2020-05-31
Completion
2020-09-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02184741 on ClinicalTrials.gov